Label: 13 FEMALE- phytolacca decandra, scrophularia nodosa, cimicifuga racemosa, calcarea carbonica, causticum, graphites, kali phosphoricum, lilium tigrinum, sulphur liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 25, 2015

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  • ACTIVE INGREDIENT:


    Phytolacca Decandra 3X, Scrophularia Nodosa 3X, Cimicifuga Racemosa 200C, Calcarea Carbonica 1M, Causticum 1M, Graphites 1M, Kali Phosphoricum 1M, Lilium Tigrinum 1M, Sulphur 1M

  • INDICATIONS:

    For the temporary relief of emotionlessness, denial, numbness, and unresponsiveness.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Feel the emotion fully, breathe deeply-connecting breaths. Put 5 drops under tongue to release emotion. Continue 5 drops 2x daily as needed. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For the temporary relief of emotionlessness, denial, numbness, and unresponsiveness.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • QUESTIONS:

    MFD FOR:

    The Wellness Center for Research and Education, Inc.

    1237 S. Victoria Ave. Suite 169

    Oxnard, CA 93035

    1-866-962-6484

  • PACKAGE LABEL DISPLAY

    Dr. Theresa Dale's

    NDC: 50181-0048-1

    Homeopathic

    Neuro-Emotional Remedies

    #13 FEMALE

    PITUITARIES/UTERUS/OVARIES

    UNRESPONSIVE

    1 fl oz (30 ml)

    13 Female

  • INGREDIENTS AND APPEARANCE
    13 FEMALE 
    phytolacca decandra, scrophularia nodosa, cimicifuga racemosa, calcarea carbonica, causticum, graphites, kali phosphoricum, lilium tigrinum, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0048
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA3 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH200 [hp_C]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE1 [hp_M]  in 1 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM1 [hp_M]  in 1 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE1 [hp_M]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC1 [hp_M]  in 1 mL
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING1 [hp_M]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 [hp_M]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0048-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/04/2014
    Labeler - The Wellness Center For Research and Education (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0048) , api manufacture(50181-0048) , label(50181-0048) , pack(50181-0048)
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